Orange Book product · Brand (NDA)
DOVATO
DOLUTEGRAVIR SODIUM; LAMIVUDINE
At a glance
Apr 08, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 08, 2019
7 yr 4 mo ago
Today
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Apr 05, 2027
in 10 mo
Patent 8129385 expires
Listed drug substance patent expiration.
Oct 05, 2027
in 1 yr 4 mo
Patent 8129385*PED expires
Listed listed patent expiration.
Apr 05, 2028
in 1 yr 10 mo
Patent 9242986 expires
Listed drug substance patent expiration.
Dec 08, 2029
in 3 yr 6 mo
Patent 9242986*PED expires
Listed listed patent expiration.
Jun 08, 2030
in 4 yr
Patent 11234985 expires
Listed drug product patent expiration.
Jan 24, 2031
in 4 yr 8 mo
Pharmaceutical detail
Active ingredient
DOLUTEGRAVIR SODIUM; LAMIVUDINE
Strength
EQ 50MG BASE;300MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 211994
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- NPPNew patient population exclusivity (3 years)
Apr 05, 2027
in 10 mo
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8129385 | Oct 05, 2027 | in 1 yr 4 mo | SubstanceProduct |
| 8129385*PED | Apr 05, 2028 | in 1 yr 10 mo | |
| 9242986 | Dec 08, 2029 | in 3 yr 6 mo | SubstanceProduct |
| 9242986*PED | Jun 08, 2030 | in 4 yr | |
| 11234985 | Jan 24, 2031 | in 4 yr 8 mo | ProductU-257 |
